ICU Medical, Inc.: 242 recalls on record

Recalls filed with 1 agency: FDA (242).

First recall on record: August 8, 2012. Most recent: September 23, 2026.

Risk classification: Class I: 15 · Class II: 227

Most recent recalls

DateAgencyProduct
November 5, 2025FDAICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360Z-0351-2026
November 5, 2025FDAICU Medical ChemosafeLock Connecter REF: KL-FNU3Z-0364-2026
November 5, 2025FDAICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10Z-0329-2026
September 10, 2025FDASmiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented …Z-2522-2025
September 10, 2025FDASmiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. …Z-2526-2025
August 13, 2025FDAPlum Duo Infusion System, List Number: 400020401Z-2129-2025
March 19, 2025FDAPOTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, I…D-0268-2025
March 19, 2025FDAPOTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, …D-0267-2025
December 18, 2024FDAChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device preve…Z-0652-2025
November 27, 2024FDAAllegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusi…Z-0482-2025
August 21, 2024FDAReplacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Inf…Z-2448-2024
August 21, 2024FDAReplacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Numbe…Z-2447-2024
August 21, 2024FDAPlum 360/A+ spare batteries. Item Number: SUB0000864.Z-2449-2024
May 24, 2023FDAASM Replacement Battery, Component Number SUB0000864Z-1567-2023
November 23, 2022FDA0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical,…D-0062-2023
September 21, 2022FDA6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP…Z-1723-2022
September 21, 2022FDAMicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Ne…Z-1722-2022
September 14, 2022FDAProduct Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/…Z-1681-2022
September 22, 2021FDAAMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx…D-0805-2021
May 19, 2021FDAREF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for t…Z-1577-2021
May 19, 2021FDAREF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; Ch…Z-1573-2021
March 31, 2021FDA0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for…D-0313-2021
December 30, 2020FDA42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin S…Z-0699-2021
December 30, 2020FDASpiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 m…Z-0706-2021
December 30, 2020FDA30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Fi…Z-0705-2021

Questions about this company

How many recalls does ICU Medical, Inc. have?
Recalert has 242 U.S. recalls on record for ICU Medical, Inc., published between August 8, 2012 and September 23, 2026.
Which agencies have handled ICU Medical, Inc. recalls?
ICU Medical, Inc. appears as the recalling firm in recalls from: FDA (242).

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